Olympus Recalls Disposable Triple Lumen Sphincterotomes Due to Potential Performance Loss
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Olympus Corporation of the Americas has issued a voluntary recall for certain Disposable Triple Lumen Sphincterotomes that may deform and lose performance during medical procedures.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevices.
What Happened
Olympus Corporation of the Americas has initiated a voluntary recall of its Disposable Triple Lumen Sphincterotome. The recall was prompted by a manufacturing issue where certain devices did not undergo the necessary thermoforming process. As a result, these instruments could deform, potentially leading to a loss of performance during use.
Which Products Are Affected
The recall affects the following medical device:
- Product Name: Disposable Triple Lumen Sphincterotome
- Model/Catalog Number: KD-401Q-0330
- Material REF: 5856730
- UDI-DI: 04953170041617
- Affected Lots: All lots with a valid expiration date
Approximately 886 units are affected. The distribution of these products is worldwide, including nationwide distribution in the United States across 45 states, the District of Columbia, and Guam.
What You Should Do
Olympus initiated the recall notification via letter on January 7, 2026. Healthcare facilities and providers should immediately check their inventory for the affected Model/Catalog Number KD-401Q-0330. Any units identified from the affected lots should be handled according to the instructions provided in the firm's notification letter. For additional information, facilities may contact Olympus Corporation of the Americas at their headquarters in Center Valley, Pennsylvania.
Why This Matters
These instruments are designed for use with endoscopes and guidewires during papillotomy procedures using high-frequency current. A device that deforms or loses performance during such a procedure could compromise the effectiveness of the treatment or lead to surgical complications.
Source
Original source: FDA Official Notice ↗
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